The Department of Health and Human Services and its Office of Civil Rights (OCR) are capping off a very active 2016. In the last 6 months, the OCR has released a new audit protocol, announced new rounds of HIPAA audits, and stepped up enforcement. The flurry of activity comes after a prolonged period of anticipation in … Continue reading
The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process. … Continue reading
On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other … Continue reading
On June 17, 2016, the Department of Health and Human Services’ Office of Inspector General (OIG) released a report entitled “CMS Is Taking Steps to Improve Oversight of Provider-Based Facilities, But Vulnerabilities Remain” (OEI-04-12-00380). The OIG reviewed oversight by the Centers for Medicare & Medicaid Services (CMS) of compliance by hospitals with the Medicare provider-based … Continue reading
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act. MAT involves the use of medication in combination with certain behavioral … Continue reading
On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.… Continue reading
In the fall of 2015, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) released an online resource to assist mobile health application developers in determining whether they need to comply with the Health Insurance Portability and Accountability Act (“HIPAA”). This week, the Federal Trade Commission (“FTC”) announced a new web-based tool … Continue reading
Yesterday, the Department of Justice launched 10 regional task forces aimed at identifying fraud at nursing homes that provide inferior care to elderly residents. Referred to as the Elder Justice Task Forces, the DOJ plans to launch the 10 regional task forces in the following districts across the country:… Continue reading
In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on … Continue reading
On January 6, 2015, the Office for Civil Rights (OCR) of the United States Department of Health and Human Services (HHS) issued a final rule modifying certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The modifications grant to certain covered entities a narrowly tailored permission to disclose limited … Continue reading
The University of Washington Medicine (“UWM”) has agreed to settle charges that it violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule for US$ 750,000, following a breach report first submitted by UWM on November 27, 2013. In addition to settlement, UWM has entered into a Resolution Agreement with the United … Continue reading
The Administration for Community Living (ACL), a division of the Department of Health and Human Services, promulgated a proposed rule on November 16 taking charge of the Independent Living Services (ILS) and Centers for Independent Living (CILS or Centers) programs. The Department of Education regulated Independent Living (IL) programs until the authority was transferred to … Continue reading
On October 20, the US Department of Health and Human Services (HHS) and Office for Human Research Protections (OHRP) held a Town Hall Meeting to further solicit comments and questions concerning proposed changes to the Common Rule, which addresses the ethical treatment of human subjects in research. As we previously noted, the proposed rule was … Continue reading
On October 5, 2015, the HHS Office of Civil Rights (OCR) unveiled a new resource to provide mobile health (mHealth) developers guidance on complying with Health Information Portability and Accountability Act (HIPAA) requirements applicable to those organizations. The portal permits developers to submit questions and offer comments on existing OCR guidance regarding how mobile medical … Continue reading
On September 2, the US Department of Health and Human Services (HHS), along with 15 other government agencies, proposed changes to the Common Rule, to enhance protections for individuals involved in research, while modernizing rules and improving efficiency. The rule will be published in the Federal Register on September 8. The Common Rule is currently … Continue reading
Today, the Department of Health and Human Services (“HHS”) issued a long-awaited proposed rule implementing Section 1557 of the Affordable Care Act (“ACA”), which makes clear that the ACA’s extension of civil rights protections against sex discrimination in health programs and activities includes discrimination based on sexual orientation and gender identity. Before the ACA, civil … Continue reading
On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The Attorney General, HHS Secretary, and FBI Director announced the charges, which allege various health care … Continue reading
The U.S. Department of Health and Human Services (“HHS”) will be heading back to District Court—and likely the drawing board altogether—to grapple with a recent federal court holding that the Medicare equipment lease rule is probably illegal. The final rule, issued in 2008, effectively prohibits physicians who lease medical equipment to hospitals from referring their … Continue reading
In an Advisory Opinion posted on June 4, 2015, the Office of Inspector General for the Department of Health and Human Services advised that a proposed arrangement involving financial assistance to individuals with chronic diseases would not constitute grounds for sanctions under either the provisions prohibiting inducements to beneficiaries or the Anti-Kickback statute. Advisory Opinion … Continue reading
In its recently published Advisory Opinion 15-07, the OIG approved a medical device manufacturer’s (Manufacturer’s) subsidies to Medicare patients in a clinical trial (Study) designed to test the effectiveness of a procedure using the Manufacturer’s specific commercial product. The OIG’s most recent opinion is significant because it pertains to a product-specific clinical trial sponsored by … Continue reading
On Friday, May 22, a Detroit-area neurosurgeon accused of performing medically unnecessary spinal surgeries pleaded guilty to health care fraud in two federal criminal cases. Dr. Aria Sabat, 39, admitted Friday before U.S. District Judge Paul Borman that his participation in a physician-owned device distributorship (“POD”) caused him to compromise his medical judgment and to … Continue reading
Earlier this week, the U.S. Food and Drug Administration (FDA) released guidance on the definition and processing of submissions for modifications and revisions to approved pharmaceutical risk evaluation and mitigation strategies (REMS). REMS are strategies to manage a known or potential serious risk associated with a drug or biological product. FDA has the authority to … Continue reading
In an Advisory Opinion posted on March 25, 2015, the Office of Inspector General for the Department of Health and Human Services stated that a proposed fee-waiving arrangement between a laboratory and physician practice could violate the federal anti-kickback statute and result in administrative sanctions, as well exclusion from participation in federal health care programs, … Continue reading
On March 24, the U.S. House of Representatives Energy & Commerce Committee’s Subcommittee on Health held a hearing entitled “Examining the 340B Drug Pricing Program.” Witness written testimony, along with the opening statements of Subcommittee Chairman Joseph R. Pitts, and Energy and Commerce Committee Chairman Fred Upton, are available at http://energycommerce.house.gov/hearing/examining-340b-drug-pricing-program. Witnesses who testified before the … Continue reading